Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
NCT ID: NCT02000921
Last Updated: 2017-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2013-12-31
2016-09-30
Brief Summary
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Detailed Description
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Eligible subjects will be provided very low nicotine content cigarettes and are told to use the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics, smoking and health history, drug and alcohol use history, mood and perceptions of the study tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and tobacco-related toxicants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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CN + combusted & non-combusted products
Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
Combusted Products
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes
Experimental cigarettes with conventional nicotine content.
VLNC + combusted & non-combusted products
Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.
VLNC cigarettes
Modified risk tobacco product
Combusted Products
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
VLNC with non-combusted products
Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.
VLNC cigarettes
Modified risk tobacco product
Non-combusted products
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
Interventions
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VLNC cigarettes
Modified risk tobacco product
Combusted Products
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted products
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettes
Experimental cigarettes with conventional nicotine content.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications.
* Subject has provided written informed consent to participate in the study
Exclusion Criteria
* Regular use of nicotine replacement or other tobacco cessation products for purpose of quitting.
* Pregnant or breastfeeding (due to toxic effects from tobacco products).
* Planned quit date within the next two months.
* Does not have a way that the research team can communicate with them by phone or e-mail.
* Not able to read and write English well enough to complete study activities without translation.
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Dorothy K Hatsukami, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota Tobacco Research Program
Minneapolis, Minnesota, United States
Countries
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References
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Hatsukami DK, Luo X, Dick L, Kangkum M, Allen SS, Murphy SE, Hecht SS, Shields PG, al'Absi M. Reduced nicotine content cigarettes and use of alternative nicotine products: exploratory trial. Addiction. 2017 Jan;112(1):156-167. doi: 10.1111/add.13603. Epub 2016 Nov 2.
Other Identifiers
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2013NTLS012
Identifier Type: -
Identifier Source: org_study_id
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